The Local Study Associate Director (Sponsor dedicated) based in Hamburg (m/w/d) will be leading Local Study Teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
In addition to leading the Local Study Teams, the Local Study Associate Director (m/w/d) may perform site monitoring as needed to support the flexible capacity model. The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
Main Responsibilities:
1. Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
2. Leads Local Study Team consisting of CRA(s), CSA(s), for assigned studies.
3. Leads the performance of the Local Study Team at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.
4. Ensures that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
5. Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
6. Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
7. Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system.
8. Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
9. Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, including any relevant translations.
10. Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected.
11. Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
12. Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
13. Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
14. Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-actively advices the monitor(s) on study related matters.
15. Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
16. Proactively identifies risks and facilitates resolution of complex study problems and issues.
17. Organises regular Local Study Team meetings on an agenda driven basis.
Required Skills and Qualifications:
18. Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
19. Minimum 3 years of experience in a Sr Clinical Research Associate role or other related fields (Medical Affairs-led or Academic-led studies).
20. Good knowledge of international guidelines ICH GCP as well as relevant local regulations.
21. Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
22. Good medical knowledge and ability to learn relevant Sponsor Therapeutic Areas.
23. Excellent understanding of the Clinical Study Process including monitoring.
24. Excellent project management skills.
25. Strong ability to prioritize and handle multiple tasks, attention to details and negotiation skills.
26. Very good knowledge of spoken and written English and German language.
27. Good ability to learn and to adapt to work with IT systems.
28. Ability to travel nationally and internationally as required
29. Location: Hamburg, Germany
"Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered”.
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